What are the responsibilities and job description for the Quality Assurance Specialist, Medical Devices position at AL Solutions?
Quality Assurance Compliance Specialist – Medical Devices
Location: Onsite in Riviera Beach, Florida
Salary: Up to $95,000 per year
Employment Type: Full-time, 40 hours per week
We are supporting a U.S.-based medical device manufacturer that designs and builds high-specification Class II medical devices within Respiratory for hospital and clinical environments. Known for engineering excellence and a strong commitment to regulatory compliance, the company has a long-standing reputation for delivering safe, effective, and durable systems that support patient care in critical settings.
As part of their ongoing growth, the company is seeking a Quality Assurance Compliance Specialist to join their onsite team in Riviera Beach, Florida. This role is ideal for someone who thrives in a regulated manufacturing environment and has the confidence to lead audits, maintain compliance systems, and contribute to continuous quality improvement.
Key Responsibilities:
- Lead and coordinate internal and external audit teams
- Develop, review, and maintain quality and compliance documentation
- Ensure ongoing compliance with ISO 13485, MDD/MDR, CE marking, and CSA standards
- Work closely with engineering, manufacturing, and leadership to support quality and regulatory goals
- Identify and implement opportunities for continuous improvement within the quality system
Requirements:
- Strong experience working with ISO 13485 quality systems
- In-depth knowledge of MDD/MDR, CE/CSA standards
- Proven experience leading audit teams and managing audit activities
- Excellent documentation and communication skills
- Must be able to work onsite 40 hours per week in Riviera Beach, FL
Nice to Have:
- Experience in a regulated manufacturing setting, ideally within medical devices
- Familiarity with FDA regulations and other international standards
This is an exciting opportunity to join a company that manufactures life-enhancing technology and takes pride in producing high-performance, compliant medical systems that make a difference in patient care.
If you’re ready for a role where your expertise will be valued and your contributions will have real impact, we’d love to hear from you.
Salary : $75,000 - $95,000
